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U.S. Department of Health and Human Services

Product Classification
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Device organ care system (ocs) heart system
Definition A portable ex vivo organ perfusion system used to preserve a donor heart for transplantation into a potential recipient.
Physical State Device includes a perfusion apparatus and may also include a preservation solution set as part of the system. The perfusion apparatus consists of an enclosure that houses the hardware and software used to control and perform functions such as perfusion, gas exchange, and temperature regulation.
Technical Method Device actively perfuses the donor hearts with a preservation solution at a normothermic or hypothermic temperature throughout the preservation period.
Target Area Donor heart
Review Panel Cardiovascular
Product CodeQIK
Premarket Review Circulatory Support, Structural and Vascular Devices (DHT2B)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible
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